Effect of Charcoal on Gastrointestinal Absorption of Tiotropium

NCT03945344 — Phase 1, Completed, 20 participants, Orion Corporation, Orion Pharma

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Effect of Charcoal on Gastrointestinal Absorption of Tiotropium; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Registry	NCT03945344, acronym TIOBLOCK
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	20 (Actual)
Sponsor	Orion Corporation, Orion Pharma (Industry)
Conditions	Healthy Volunteer Study
Interventions	Tiotropium (Drug)
Dates	start 2019-05-27, primary completion 2019-06-19, completion 2019-06-19, first posted 2019-05-10, last updated 2019-09-23
Locations	1 site in Finland

-Summary

The study will assess how efficiently activated charcoal will block absorption of tiotropium via the gastro intestinal track. Pharmacokinetics of tiotropium will be compared after orally administered tiotropium capsule with and without concomitant activated charcoal administration in healthy volunteers.

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+Arms and interventions

Arm	Type	Interventions	Description
Treatment A	Experimental	Drug: Tiotropium	Tiotropium with concomitant charcoal
Treatment B	Experimental	Drug: Tiotropium	Tiotropium without concomitant charcoal.

Tiotropium (Drug): Oral capsule 20 μg
Tiotropium (Drug): Oral capsule 20 μg

+Outcome measures

Primary outcomes

The pharmacokinetic parameter Area Under Curve (AUC) [24 hours]

Secondary outcomes

Peak concentration in plasma (Cmax) and time to reach peak concentration in plasma (tmax) [(0 hours) and at 15, 30 and 45 minutes, and 1,1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours after the administration]

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria:

1. Written informed consent (IC) obtained.
2. Healthy males and females, aged 18-60
3. Normal weight at least 50 kg.

Exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
2. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
3. Any clinically significant abnormal laboratory value or physical finding that may interfere the interpretation of study result or constitute a health risk for the subject if he/she participates in the study.
4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or to the excipients of the drug.
5. Pregnant or lactating females.
6. Females of childbearing potential not using proper contraception.

+Locations (1)

Facility	City	Country	Status
Clinical Pharmacology Unit	Espoo	Finland

+Investigators

Maria Annunen, MSc, Study director, Orion Corporation, Orion Pharma